Good day, welcome to the Myomo fourth 1/4 and full year 2025 financial results. All participants will be in a Listen-Only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by 0.
After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your Touch-Tone phone. To withdraw your question, please press star then 2. Please note this event is being recorded. I would now like to turn the conference over to Mr. Tirth Patel with Alliance Advisors IR. Please go ahead, sir.
Thank you, operator. Good afternoon, everyone. This is Tirth Patel with Alliance Advisors IR. Welcome to the Myomo fourth 1/4 and full year 2025 financial results conference call. With me on today's call are Myomo's Chief Executive Officer, Paul Gudonis, and Chief Financial Officer, David Henry.
Before we begin, I'd like to caution listeners that statements made during this call by management other than historical facts are Forward-Looking statements. The words anticipate, believe, estimate, expect, intend, guidance, outlook, confidence, target, project, and other similar expressions are typically used to identify such forward-looking statements.
These forward-looking statements are not guarantees of future performance and may involve and are subject to risks, uncertainties, and other factors that may affect Myomo's business, financial condition, and operating results. These risks, uncertainties, and other factors are discussed in Myomo's filings with the Securities and Exchange Commission.
Actual outcomes and results may differ materially from what's expressed in or implied by these forward-looking statements. Except as required by law, Myomo undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call today, March 9, 2026. It's now my pleasure to turn the call over to Myomo CEO, Paul Gudonis. Paul, please go ahead.
Thanks, Tirth. Good afternoon, and thank you all for joining us today. During our last quarterly call, I outlined four major objectives for the company. One, continue to grow revenue through our direct-to-patient marketing, as well expand the number of orders from recurring sources, namely the Orthotics and Prosthetics channel and the MyoConnect referral program.
Number 2, increase market access for patients by signing additional payer contracts and engaging with Medicare Advantage and commercial plans for coverage. Number 3, manage our cost structure and enhance our manufacturing processes to demonstrate operating leverage as we scale. Number four, continue to innovate in product development to maintain our market leadership position.
I'm pleased to report that we made progress on all four of these objectives. Fourth 1/4 of 2025 was our strongest revenue 1/4 of the year, with $11.4 million in revenue.
This brought our full year revenue to $40.9 million, representing 26% growth over 2024. We also recorded the highest number of orders in the company's history, with 241 MyoPros ordered during the 1/4, up 5% sequentially from the 1/3 1/4.
This growth was driven by expanded penetration of the O&P channel, the early success of our MyoConnect clinical referral program, and stronger international revenues. Over the past year, we launched the MyoPro Center of Excellence program to educate domestic O&P practices on the new MyoPro 2X product and the improved reimbursement environment.
O&P providers from national and regional chains to local independent practices ordered approximately 100 MyoPros last year.
In addition, quarterly revenue from the U.S. O&P channel exceeded $1 million for the first time, and our revenue from the O&P channel was up 81% for the 1/4 and doubled for the year. To capitalize on the clinical relationships we've developed with therapists at rehab hospitals across the country, we established the MyoConnect program to engage therapists and physicians in referring medically qualified patients to Myomo and our O&P partners.
In just the first 6 months of this program, we've had over 100 qualified candidates enter our patient pipeline, and referrals were nearly 10% of total pipeline adds in the fourth 1/4. We'll continue to lean into the MyoConnect program in 2026 as we focus on growing revenues from recurring patient sources.
MyoConnect makes sense for clinicians since they want better outcomes for their patients, and these rehab hospitals will continue to provide therapy and training support based on the MyoPro protocol. This strategic pivot to recurring patient sources is already evident in our results. Back in the fourth 1/4 of 2024, 26% of our revenue came from recurring sources.
By the fourth 1/4 of 2025, that figure had increased to 42%, representing 52% Year-Over-Year growth. Supporting the above revenue initiatives is a revised marketing plan that's raising awareness of our products to healthcare professionals and further optimizing our digital marketing to patients.
We believe these initiatives, along with better insurance coverage, will reduce our acquisition costs per customer. Our international operations delivered quarterly revenues in excess of $2 million for the first time, growing 46% for the 1/4 and 48% for the year.
The increase was due to growth in the patient pipeline, more O&P clinics and medical professionals sourcing patients for MyoPro, favorable reimbursement policies from statutory health insurers, and some foreign exchange tailwinds. We're adding more business development and clinical staff to our team in Germany, and we expect continued growth in that market in 2026.
Over in China, we became aware toward the end of the year that the majority shareholder in the joint venture, Ryzur Medical, ran into financial problems in its core rehab hospital business and declared bankruptcy. As a result, operations of the JV company are on hold at this time.
As you may recall, we received $2.7 million in upfront license payments a few years ago, and we're now working with China Lead Ventures, a major investor in the JV, to see if the venture can be recapitalized and restructured so they can address that very large market opportunity in that country. Our market access strategy here in the U.S. continues to gain traction, and we've signed in-network contracts with additional Medicare Advantage and commercial payers in the past several months.
Most notably, we recently reached a multi-state agreement with Elevance Health, which allows us to begin executing State-By-State in-network contracts across their network, which covers 45 million lives. This represents our first such extensive payer arrangement, which provides for case-by-case authorization. This is significant since we are seeing an increasing number of authorizations from plans where we have a contract.
Since we have these agreements on pricing, we don't have to go through a lengthy single case agreement process, and that speeds up the patient's access to MyoPro and our revenue cycle. Our 1/3 major initiative is to manage our cost structure. We've taken steps to increase our organizational efficiency, reduce the cost of outside services, and continue to drive down material costs for manufacturing the MyoPro units.
We're becoming more efficient while investing in critical R&D projects to build on our market leadership. In Q2 of this year, we plan to activate the Myomo mobile app for patients and clinicians, which is now available as a free download in the Apple and Google App Stores.
The app provides enhanced capabilities and data collection for users, while allowing us to reduce the cost of goods sold by eliminating the need to ship a laptop, including our proprietary software, to each MyoPro user. Meanwhile, we expect to roll out other enhancements this year while developing the next generation MyoPro 3.
Another R&D investment we're making is in a randomized controlled trial that's being conducted by the Craig H. Neilsen Rehabilitation Hospital, and this is expected to add to the growing body of research publications, including the 2 that were released last year. In summary, we're making significant progress in our strategic pivot to recurring patient sources, an increased number of insurance authorizations and O&P channel orders, and a lower cost structure as we intend to cut the cash burn in 1/2 in 2026.
With that overview of our results and actions, I'll turn the call over to our CFO, David Henry, to provide more of the financials and details.
Thank you, Paul, and good afternoon, everyone. As Paul mentioned, we saw full-year revenue growth of 26%, driven by growth across all of our sales channels, led by the U.S. O&P channel and international, which both had record 1/4s. Revenue for the fourth 1/4 of 2025 was $11.4 million, which was our highest revenue 1/4 this year, up 13% from the 1/3 1/4 of 2025, but down slightly versus the prior year period.
The Year-Over-Year decrease was driven by a lower number of revenue units and a slightly lower average selling price, or ASP. In addition, in the fourth 1/4 of 2024, we experienced stronger Medicare Advantage revenue and filled demand from Medicare patients after beginning to cover the MyoPro earlier that year.
We delivered 208 MyoPro revenue units during the 1/4, down 5% Year-Over-Year, but up 12% sequentially. 62% of fourth 1/4 revenue units were generated from authorizations received during the 1/4. In addition, our ASP decreased less than 1% versus the prior year to approximately $54,600, due primarily to channel mix.
Medicare Part B patients represented 49% of revenue in the fourth 1/4. Medicare Advantage patients represented 20% of fourth 1/4 revenue and in dollar terms was down 11% compared to the prior year 1/4.
As I'm sure you have seen with other companies, it's been a challenging year dealing with Medicare Advantage payers who have constrained this by issuing a high number of pre-authorization denials, necessitating an appeals process in order to serve these patients.
We have and will continue to fight these denials to make our product available to patients who are in need. As we enter into more payer contracts, we are seeing more authorizations under those agreements. Not enough so far to replace the volume from payers that previously authorized more routinely.
We continue to work to secure more payer contracts and are encouraged by our first multi-state payer arrangement with Elevance. 69% of revenue in the fourth 1/4 came from the direct billing channel, compared with 81% in the prior year 1/4.
Direct billing revenue was down 20% Year-Over-Year due to lower Medicare and Medicare Advantage authorizations and challenges with social media lead generation we faced in the first 1/2 of 2025. Partially offsetting lower direct billing revenue were solid results in our other sales channels.
International revenue was a record $2.2 million, up 46% Year-Over-Year, and representing 19% of total revenue, primarily from Germany. The U.S. O&P channel also achieved a milestone, reaching a record $1 million in quarterly revenue, up 81% Year-Over-Year and representing 9% of total revenue. Recurring patient sources, including referrals under our MyoConnect program, international, U.S. O&P, and the VA, represented 42% of fourth 1/4 revenue.
As of December 31st, 2025, the pipeline stood at 1,528 patients, an increase of 10% Year-Over-Year. During the fourth 1/4, we added 676 patients to the pipeline, which is up 3% from the prior year 1/4. We exited the 1/4 with a backlog of 199 patients.
A record 241 orders in the 1/4, combined with the smooth-running operations, resulted in a record 62% of fourth 1/4 revenue units coming from intra-1/4 fill units, up from 35% of revenue units a year ago. Gross margin for the fourth 1/4 of 2025 was 68.6%, down from 71.4% a year ago and up from 63.8% in the 1/3 1/4.
The Year-Over-Year decrease was due to a lower amount of overhead capitalized inventory compared to the prior year period and higher warranty expenses. Operating expenses for the fourth 1/4 of 2025 were $10.6 million, up 19% over the prior year 1/4. This increase was driven primarily by higher sales, clinical and marketing expenses, particularly advertising expense, which was up approximately $1.2 million Year-Over-Year.
Advertising spending in the fourth 1/4 was down 4% sequentially. Operating loss for the fourth 1/4 of 2025 was $2.8 million, compared with an operating loss of about $200,000 in the prior year 1/4.
Fourth 1/4 Non-Operating expenses include a One-Time Write-Off of debt issuance costs, cash interest expense under the Avenue term loan, Non-Cash interest expense for the amortization of discounts on the debt, and a loss on the change in fair value of derivative liabilities bifurcated from the debt on the issuance date and recorded as separate liabilities which must be marked to market to fair value each 1/4. Net loss for the fourth 1/4 of 2025 was $3.8 million, or $0.09 per share. This compares with a net loss of $300,000 or $0.01 per share for the fourth 1/4 of 2025.
Adjusted EBITDA for the fourth 1/4 of 2025 was a negative $1.9 million, compared with a positive $200,000 for the fourth 1/4 of 2024. Before I move to the balance sheet, let me give you a quick summary of some selected full year results. As I mentioned, revenue was $40.9 million, up 26%. Gross margin for the year was 65.7%, compared with 71.2% for 2024.
The decrease was due to higher overhead costs, primarily due to our facility move earlier this year. Investments in R&D, which resulted in the launch of the MyoPro 2X, our Mark 2 unit, and progress on the MyoPro 3 in 2025, as well as higher sales and marketing expense, drove the increase in operating expenses to $41.3 million in 2025, compared with $29.4 million in 2024.
Turning now to our balance sheet and cash flow. As of December 31st, 2025, cash equivalents and short-term investments were $18.4 million. Cash burn, which we define as free cash flow, was $1.5 million in the fourth 1/4, excluding the net proceeds from the Avenue term loan, repayment of the debt to Silicon Valley Bank, and issuance fees and expenses.
Operating cash flow was a negative $1.1 million in the 1/4, compared to a positive $3.4 million in the fourth 1/4 a year ago. Let me conclude my remarks with financial guidance. As Paul mentioned, we are approaching 2026 as a year where we orient our business more towards stroke patients in the incidence population and recurring patient sources through our MyoConnect referral program, increasing engagement with the U.S. O&P channel, as well as continued international growth.
Our near-term objective to generate a majority of revenue from recurring sources is expected to make the business easier to scale. To fund this transition, we will continue to advertise direct to patients, but limit the growth in advertising spending while building out our MyoConnect program and adding direct sales resources to support the O&P and international channels.
As a reminder, first 1/4 revenue tends to be seasonally lower and expenses higher, with payroll taxes and employee benefits resetting. In line with this historical seasonality, first 1/4 revenue is expected to be in the range of $9 million-$9.5 million. With sequentially lower revenue and operating expenses expected to be slightly higher sequentially, we expect first 1/4 operating loss to be higher than fourth 1/4 2025. For 2026, we expect revenue to be in the range of $43 million-$46 million.
We expect gross margin to benefit from higher volume and lower cost of goods sold per unit, as well as a 2% Medicare price increase effective January 1, 2026. In addition, we expect to generate operating leverage and limit the growth of other operating expenses. We expect to limit the growth of OpEx to 1/2 the growth of revenue in 2026.
With gross margin expected to increase in 2026 and operating cost management, we expect a lower operating loss in 2026, and that cash burn or free cash flow will be reduced by roughly 1/2 in 2026 compared with 2025, driven by the higher revenue and gross margin, partially offset by investment in R&D and sales and marketing, as well as interest expense on our debt. We are committed to growing the top line while prudently investing in the business.
With that overview, I'll turn the call back to Paul.
Thanks, David. Well, to summarize, in 2025, we saw a 26% revenue growth. We launched the MyoPro 2X. We invested in developing the next-gen MyoPro 3. We generated several million dollars in orders from the new O&P channel. We Re-Grew the recurring revenue portion of our business by over 50%. We also expanded our addressable market by engaging patients right after their stroke while they're still in the rehab centers, in addition to the large prevalence population with chronic arm paralysis.
For example, we just provided a MyoPro to a 36-Year-Old male who had a stroke last year and was referred to us by his therapist. With our contract with his Blue Cross Blue Shield plan, he was quickly approved for the device and received it within a year of the incidence of his stroke.
As we look ahead to this year, we plan to continue this go-to-market transition, reduce our customer acquisition costs, and demonstrate that operating leverage with a lower cost structure. While the untapped market for our product remains vast, with hundreds of thousands of potential patient candidates representing a large long-term opportunity.
Given our sales and marketing transition and the uncertainty around the behavior of the Medicare Advantage payers, we believe it's prudent to be conservative and guide to approximately 10% revenue growth with improvement in adjusted EBITDA. We're looking forward to updating you on our progress as the year unfolds. We're now ready to take your questions. Operator?
Thank you. We will now begin the question-and-answer session. To ask a question, you may press Star then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press Star then 2. At this time, we'll pause momentarily to assemble our roster.
While we're waiting for the first question.
The first question. Go ahead, sir. I'm sorry.
Well, yeah. Chuck, I was gonna say, while we're waiting for the first question, I do wanna mention that we're planning to host another investor analyst day for an update on the business, and we'll provide details on this event at a later date. We hope to speak with many of you there. Okay, operator, let's go with the first question.
The first question will come from Chase Knickerbocker with Craig-Hallum. Please go ahead.
Good afternoon. Thanks for taking the questions. Maybe just first, you noted progress on MyoConnect, though cost per pipeline ad, you know, increased in the 1/4. Can you just detail what maybe drove that up in the 1/4? Then can you talk about kind of the plan on the direct side of the business to kind of get that acquisition cost down? Thanks.
Thanks, Chase. The MyoConnect program is gaining traction. We're getting these referrals, there's no advertising cost around that. Fourth 1/4, as we've mentioned in the past, tends to have a higher advertising cost because you were competing with holiday advertising. There may be election cycles in some cases.
Our pipeline ads, when you divide by the, you know, into the advertising costs were higher than we like. What we've done is, we brought on a new head of marketing. She started at the end of last year. We brought on a new digital marketing agency in January. They've gotten started revamping our digital marketing approach and social media. We've introduced new TV creative for that advertising, and we've seen the cost per call go down.
You know, we expect that all these different actions should take down that cost per pipeline ad over time, especially with more referrals where there's a 0 advertising cost associated with it.
Have you seen any of that improvement so far as we've kinda came into Q1?
Well, we're not really discussing Q1 at this time. I will say, though, it is kind of a little bit early. I mean, the ad agency just really started, I would say, within the last 6 to 8 weeks, you know, really starting to, you know, do their work. It's a little bit too early to talk about results at this time. I think we'll give you a better update when we report in May the first 1/4 results.
Got it. Maybe just a couple more details on the O&P channel, if you would. Can you give any sort of, any sort of kind of KPIs around kind of ordering number, like number of clinics that ordered in the 1/4, you know, some sort of active account number? Can you just give us the number of units through the O&P channel in Q4? Was ASP kinda solid there, Q3 to Q4? Thanks.
We've got a couple of dozen O&P providers that have been trained, certified, and are ordering the MyoPros, and we had over $1 million of revenue in the 1/4. On an average price there, some 30 some units. Dave?
It was about 36 O&P units in the fourth 1/4.
Got it. Maybe just, the last one for me, just on 2026 guidance, can you just, kind of detail what your assumptions are there for that U.S. O&P business as far as what it'll co-contribute to that 2026 guidance?
Well, we're expecting growth in the O&P channel and in international. That's what's going to drive the growth this year. I think direct billing is gonna be relatively flat if you, if you look at it. That's because it's just we're too soon into these marketing changes to really, you know, have some conviction that and to say that direct billing is going to grow.
You know, we're trying to limit the amount of spending on advertising because we are trying to, we've seen the results, you know, in the last 1/2 of 2025, and the cost per pipeline ad is unacceptably high.
We have to, you know, we need to see that being addressed before we'll decide to spend, you know, more money on advertising beyond what we're already spending. The MyoConnect program is kind of really ramping up.
You know, there's some, you know, just uncertainties some uncertainty as we wait to see how these marketing changes will flow through to get some, you know, better visibility on what that channel might look like for 2026. We're working really hard to grow those recurring patient sources because as Paul mentioned, you know, the cost per pipeline ad there is minimal, and we're all about trying to increase operating leverage, reduce cash burn while at the same time growing revenue in 2026.
Understood. Thank you.
The next question will come from Scott Henry with AGP. Please go ahead.
Thank you. Good afternoon. Starting from the top of the funnel pipeline ads, 676 is a little lower than it's been in the past couple quarters. Do you see that as an aberration? Are you getting higher quality ads? You know, alternatively, should we see that bounce back towards some of the higher levels we saw in the middle of the year? Thank you.
Yeah. I think, a key will be the, you know, the success of MyoConnect to generate some pipeline ads. You know, we're not going to spend more on advertising. We're gonna try to keep that spending relatively flat Year-Over-Year. That's where the sources are going to come from.
We did have, you're right, 676. It was a little bit lower. I will say, though, that we did shut down for about in the last 9 days or so of 2025. That did have a little bit of effect on pipeline ad generation. We had about 2 less weeks in the fourth 1/4 compared to the 1/3.
Like I said, I think it's, you know, we're really looking to see the MyoConnect program gain some traction and try to bring more pipeline ads at a much reduced cost per pipeline ad here in 2026.
Okay. We'll continue to track that. Also the dropout rate, I think by my calculations, was around 40%. I guess that could change a little bit depending how you calculated it. A little bit higher, not dramatically higher than past 1/4s, but any comments on that rate?
This is the backlog drop rate, correct?
Yes.
Yeah. It was about, by my calculations, it was a little over 20%.
Okay. The trend should be the same, depending... I'm just backing it out of the reimbursement pipeline. If you add all the ads and you subtract the units placed, you come up with a number.
Yeah. I would say you're talking about a pipeline drop rate then.
Yes.
Okay. Yeah. I was referring to backlog. Sorry.
Oh.
I haven't calculated the pipeline drop rate. I'll take your word for it was around that. I mean, there's.
It's a little bit higher than...
Yeah, the overall pipeline, you know, the pipeline did decrease, and a lot of that was probably because of drops. There's been a lot of Medicare Advantage patients that have been accumulating in the pipeline that we're having, you know, they're making it hard on us to get authorized. And as a result, a lot of them, you know, we're seeing a lot of drop-offs as a result of that.
Okay.
On the other hand, Scott, what we are seeing is, especially from the referring therapist, because we've encouraged them to, you know, check insurance and so on, we're seeing more Medicare-qualified patients coming to us from their referral channel, which means, there's a, you know, a higher probability that they will get approved for their MyoPro.
Okay. Thank you for the color. The final question, gross margins were very strong in the 1/4, and you mentioned they could get even stronger, at least in the press release. From that kind of 68%-69% level, do you think that could be a new baseline? Kinda how high can that go? Because it's obviously a pretty good number for the 1/4.
Yeah. It will fluctuate with volume, I would expect first 1/4 gross margin will be lower than fourth 1/4 just because of the, you know, less units absorbing overhead. As we go through the year, you know, the, you know, the guidance implies increasing revenues as we go through the 1/4s of 2026.
That will help the gross margin in addition to, you know, we're, you know, we're working on about, as we mentioned actually last Analyst Day, around 200 basis points of gross margin improvement from various activities. Paul mentioned the mobile app that will be, we expect that to be released here in the coming weeks.
That will help, you know, take out about $400-$500 of cost out of the MyoPro because we're not providing a laptop anymore. There's other cost reduction projects that we're working on as well. We, you know, so I think that, we're trying to get that gross margin back up into the, into the 70% range here, by the time we exit 2026.
Okay, great. Thank you for taking the questions.
Mm-hmm.
The next question will come from Anthony Vendetti with Maxim Group. Please go ahead.
Thank you for taking my question. First one was related to the O&P clinics. I think if I recall correctly, you mentioned in last year's investor day that you were planning on having roughly 200 clinics trained, certified, and to be able to deliver the MyoPro in 2028. Is that still, you know, a goal that's on track? You know, how fast is this O&P ne2rk expanding?
You know, that is still a goal of ours. You know, we have a number of clinics that, you know, they're earlier stage, you know, where they're just getting trained. They're building their patient pipelines. They're getting the reimbursement, and so then they will turn into orders.
We also have a very robust national account programs because there's been consolidation in the industry where there's been a number of players that own 40 to 50, 80 or so clinics, and we've been doing national account planning with these entities where they're starting out with a couple of their regions, piloting it, getting some good results, and then we'll see greater rollout. I think, look, this is the most powerful new product opportunity to be address a big unmet need.
I'm very bullish about the O&P channel adopting the MyoPro into their clinical treatment plans.
Okay, great. Then, you know, switching maybe to reimbursement cycle times. I think, again, in the past, you've mentioned numerous times, it's roughly 6 months, I think, from, you know, when a patient reaches out until you actually get payment. Now that you're signing up more of these payers, does that reimbursement, you know, cycle time, are you seeing improvements or it's still roughly that 6-month timeframe?
Well, I think the, the bigger improvement is coming from the fact that we're, you know, Medicare is now, you know, roughly 1/2 of our revenues. Medicare reimburses pretty quickly. You know, we can generally get, we can get paid in, you know, 3 weeks, and we're recording revenue on delivery.
The, you know, the most, I would say the majority of our revenues are occurring at delivery, though I will say, that, one of the things that we see with the backlog here is that as we have more contracts and the payer base broadens, not only are we seeing, you know, contracted payers, you know, authorized, but also non-contracted payers.
We're actually seeing a bit of an increase in the non-contracted payers, authorizing the MyoPro, which means we're waiting till payment to get revenue. We're starting to see a little bit of that. It's sort of good news that there are, you know, a broader base of payers now reimbursing for the device.
Okay, great. Just last question from us. You know, what I might have missed this earlier in the call, but what % of the pipeline add was from this new recurring referral sources as opposed to, you know, maybe some of the direct in the past? Also, do you have a target goal % of, you know, how you wanna see that breakdown in the future?
The pipeline adds were about 10% of the pipeline adds and about 10% of the orders were from referrals in the fourth 1/4. In terms of the way we're thinking about what that, what success might look like here in the near term is we're looking to get the revenues from recurring sources to approach 1/2 of our revenues here by the end of 2026. I think that's the near term objective that we're focused on.
Okay. Thank you very much for taking my questions. I'll hop back into queue.
The next question will come from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.
Hey, good afternoon, guys, and thanks for taking our questions. First on the German market, it's great to see that it grew really well since the end of last year. I was just wondering if you could provide some color on what were the main drivers behind this growth and how do you expect that market to go in 2026.
I'm sorry, you cut out a little bit. Which market were you referring to? International?
Germany market, yes.
Well, Germany is a large market, you know, with over 80 million population, 1% prevalence. You're talking about 800,000 prevalence population plus, again, all these incidences. Our team has done a good job recruiting a number of O&P practices around the country there. We've gotten very good social court rulings.
Many statutory health insurance companies will pay for the MyoPro, so we don't face the same reimbursement issues there in Germany as we do in the U.S. That's why it's a very good market, grew over 40% and we're continuing to invest in scaling that operation.
Great. Thanks for that. My second question is on the randomized controlled trial that's going on in University of Utah. If this study is successful, how will you use this data, in your commercial efforts, and where do you think it will help the most?
The good news is that the IRB was just approved for this trial. It's an RCT, patients with MyoPro versus those that don't get a MyoPro as a control group. We should start seeing the first readouts by the end of this year. Our plan is to use that, like we've used the other research, to basically convince more payers that they should be covering the cost of the MyoPro because it's not experimental, it's not investigational, and it is medically reasonable and necessary.
That's our plan is that will just reinforce The research that's already been published, that's been accepted by CMS and many other payers, just like this new Elevance agreement we entered into and announced today.
Fantastic. That's very helpful. Our last question is on the R&D efforts for MyoPro 3. Could you provide some timeline for the 3.0 model? What are the primary clinical manufacturing advantages of the 3.0 versus the 2X?
This will be a next generation platform. We are revamping everything about the MyoPro from the chip that's in the device, the software that's out there, the sensing systems, the orthotic materials, the hand grasp capability, elbow motor, harness. It's a total redo of the MyoPro to provide more functional benefit for the patients. It'll be customizable like the current one is, but just provide more function, comfort, and hopefully get even greater market adoption because of it.
Excellent. Thank you for, again, for taking our questions. That's all we have.
The next question will come from Edward Woo with Ascendiant Capital. Please go ahead.
Yeah, thanks for taking my question, and congratulations. I was questioning, in terms of As you guys continue to grow international, what's the gross margin % in international compared to domestic, and what is your operating leverage opportunity? Thank you.
I've often said that in terms of the ASPs, the international business has the second highest ASP compared to the, you know, compared to the, like, the Medicare allowable here in the U.S. The gross margin will be a little bit lower on international. If we're at about a 68% gross margin in the fourth 1/4, international will be a little bit lower than that.
How much leverage do you have in the model to increase it as your sales grow?
I think, you know, all the manufacturing is here in the U.S. As we put more volume into the facility here, you know, the gross margin in Germany will benefit just as the, you know, the overall company gross margin benefits.
Great. Well, thanks for answering my questions, and I wish you guys good luck. Thank you.
Thank you, Ed.
Again, if you have a question, please press star then one. This will conclude our question and answer session. I would like to turn the conference back over to Mr. Paul Gudonis for any closing remarks. Please go ahead.
Well, thanks, operator. Well, the actions we've taken over the last 6 to nine months have already demonstrated progress for achieving our goals of creating a growing profitable company, addressing this large unmet need of chronic arm paralysis.
We're planning for a record number of MyoPro orders this year with a growing contribution from these recurring patient sources. We expect to lower our customer acquisition costs with the new approach to digital and TV advertising and the shift to the new O&P and rehab hospital channels.
Our lowered cost structure and these projects to reduce our manufacturing costs should result in improvements in our gross margin. We continue to innovate in product development to maintain our market leadership position. Thank you all for your questions and your interest in Myomo. Have a nice evening.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.